Atlas FDA

2013

3,052 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MEDLINE ANTI-REFLUX VALVE (K132314)Medline Industries, Inc.2013-09-18
ALPHA-PRO WHITE VARNISH (K124025)Dental Technologies, Inc.2013-09-18
TRANSTEK GLASS BODY FAT ANALYZER (K131394)Guangdong Transtek Medical Electronics Co., Ltd.2013-09-18
SMARTBUILDER SYSTEM (SB1) (K130840)Osstem Implant Co., Ltd.2013-09-18
ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM (K130232)Jinxinbao Electronic Co.,Ltd2013-09-17
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL (K130595)Zimmer, Inc.2013-09-17
ABL90 FLEX ANALYZER (K131988)Radiometer Medical Aps2013-09-17
MAXLOCK EXTREME SYSTEM (K132591)Orthohelix Surgical Designs, Inc.2013-09-17
EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, (K131161)CIVCO Medical Instruments Co., Inc.2013-09-17
VCARE A (K121817)IVT Medical, Ltd.2013-09-17
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA (K132590)ArthroCare Corporation2013-09-17
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (K131745)Helix Medical, LLC2013-09-17
CRYSTALSERT DELIVERY SYSTEM (K132593)Bausch & Lomb2013-09-17
CREODENT SOLIDEX CUSTOM ABUTMENT (K113738)Creodent Prosthetics, Ltd.2013-09-17
FACIAL SPA (K122711)Nuskin2013-09-17
ANSWATCH WRIST MONITOR MODEL TS-0411 (K123130)Taiwan Scientific Corporation2013-09-17
DIGITAL FLAT PANEL X-RAY DETECTOR (K131114)Rayence Co., Ltd.2013-09-17
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K131830)Edan Instruments, Inc.2013-09-17
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT (K131977)GE Healthcare2013-09-17
HEARTSPAN STEERABLE INTRODUCER KIT (K132164)Merit Medical Systems, Inc.2013-09-17
ERCHONIA EMERGE (K130996)Erchonia Medical, Inc.2013-09-16
PNEUPAC PARAPAC PLUS (K123957)Smiths Medical International , Ltd.2013-09-16
RAMPART-O, RAMPART-T (K132053)Spineology, Inc.2013-09-16
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) (K130802)Shenzhen Dongdixin Technology Co., Ltd.2013-09-16
ELECTROSURGICAL GENERATOR (K130760)Beijing Jinhengwei Technology Development Co., Ltd.2013-09-16
HEART SYNC (K131494)Heart Sync, Inc.2013-09-16
NOVOKNEE TOTAL KNEE SYSTEM (K131398)Novosource, Inc.2013-09-16
DEPUY CORAIL AMT HIP PROSTHESIS (K123991)Depuy France S.A.S.2013-09-16
CAS PSI KNEE SYSTEM (K131409)Orthosoft, Inc.2013-09-13
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM (K124031)Intuitive Surgical, Inc.2013-09-13
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M (K130873)Vital Access2013-09-13
ADVIA CENTAUR FT4, ADVIA CENTAUR T4 (K132249)Siemens Healthcare Diagnostics, Inc.2013-09-13
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN (K132573)bioMerieux, Inc.2013-09-13
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K132175)Edwards Lifesciences, LLC2013-09-13
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM (K132578)Boston Scientific Corp2013-09-13
UROLIFT SYSTEM (DEN130023)Neotract, Inc.2013-09-13
CEROX (K131854)Or-Nim Medical , Ltd.2013-09-13
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) (K123902)Oktx, LLC2013-09-13
TANYX (K123866)Medecell Us, Inc.2013-09-13
VYSIS D7S486/CEP 7 FISH PROBE KIT (K131508)Abbott Molecular, Inc.2013-09-13
PIONEER ELITE DIODE LASER (K131059)CAO Group, Inc.2013-09-13
LOBSTER AUTO-INJECTOR (K124026)Scandinavian Health Limited2013-09-13
SASMAR ORIGINAL, SASMAR CLASSIC (K131084)Sasmar, Inc.2013-09-13
LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE (K130641)Binder Biomedical, Inc.2013-09-13
AUTOMATIC BLOOD PRESSURE MONITOR (K130925)Honsun (Nantong) Co., Ltd.2013-09-12
QXLINK (K132302)Vieworks Co., Ltd.2013-09-12
VIVORTE BVF (K130703)Vivorte, Inc.2013-09-12
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S (K130417)Audifon-USA, Inc.2013-09-12
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (K131802)Depuy Spine, A Johnson & Johnson Company2013-09-12
IPROPHY MOBILE (K131578)Nakanishi, Inc.2013-09-12
UNIVERSAL PASTE STAINS AND GLAZE (K130604)Prismatik Dentalcraft, Inc.2013-09-12
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (K132198)Ceremed , Inc.2013-09-12
ACCULIF TL AND PL CAGE (K132505)Coalign Innovations, Inc.2013-09-12
MULTISTIM (K132137)Metron Medical Australia, Pty, Ltd.2013-09-12
SURGICAL GOWN (EO STERILIZED) (K112796)Cobes Industries Co., Ltd.2013-09-12
JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE (K124037)Jung Rim Medical Industrial Co., Ltd.2013-09-12
PULSE OXIMETER (K131021)Nonin Medical, Inc.2013-09-11
XTAG CYP2C19 KIT V3 (K131565)Luminex Molecular Diagnostics, Inc.2013-09-11
KITAZATO IUI CATHETER (K131491)Kitazato Medical Co., Ltd.2013-09-11
IHEALTH FINGERTIP PULSE OXIMETER (K131111)Andon Health Co, Ltd.2013-09-11
SHOFU BLOCK HC (K130841)Shofu Dental Corporation2013-09-11
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, (K131208)Bausch & Lomb, Inc.2013-09-11
APEX UNIVERSAL ADHESIVE (K131043)Apex Dental Materials, Inc.2013-09-10
RETROGRADE FEMORAL NAIL (K132005)Advanced Orthopaedic Solutions, Inc.2013-09-10
CCS-200 SPIROMETER (K123896)Benson Medical Instruments Co.2013-09-10
TIGER SPINE SYSTEM (K131250)Corelink, LLC2013-09-10
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST (K123567)Church & Dwight Co., Inc.2013-09-10
RESPIRE PINK SERIES - HERBST (K131138)Respire Medical2013-09-09
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION (K132216)Bausch & Lomb, Incorporated2013-09-09
BIOSIGN FLU A + B, STATUS FLU A & B (K132465)Princeton BioMeditech Corp.2013-09-09
POWER FREE VINYL EXAMINATION GLOVES (K122102)Wang Tong Xinghua Co., Ltd.2013-09-09
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE (K132073)St Jude Medical2013-09-09
FRESENIUS LIBERTY CYCLER (K123630)Fresenius Medical Care North America, Design Cente2013-09-09
THERMAGE CPT SYSTEM (K132431)Solta Medical, Inc.2013-09-06
PEAK Z (K131357)Ultradent Products, Inc.2013-09-06
ALIVECOR HEART MONITOR (K130409)AliveCor, Inc.2013-09-06
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES (K121844)Worldmed Manufacturing Sdn. Bhd.2013-09-06
EYESEECAM VHIT (K131681)Interacoustics A/S2013-09-06
FIRECR DENTALIMAGING SYSTEM (K131442)3Disc Americas2013-09-06
QUIDEL MOLECULAR RSV + HMPV ASSAY (K131813)Quidel Corp.2013-09-06
XPERCT REL. 3 (K130893)Philips Medical Systems Nederland B.V.2013-09-06
LIAISON XL HCG (K131037)DiaSorin, Inc.2013-09-06
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST (K132324)Medos International SARL2013-09-06
SINGLE USE GROUNDING PAD (K132136)Lccs Products Limited2013-09-06
STRAWBERRY, STRAWBERRY & CREAM (K130341)Laser Lipo Limited2013-09-06
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K121033)Ventana Medical Systems, Inc.2013-09-06
PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K130010)Nanostring Technologies2013-09-06
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET (K122235)Teleflexmedical, Inc.2013-09-06
FREEMIE BREAST COLLECTION SYSTEM (K130349)Dao Health2013-09-06
GORE SEAMGUARD REINFORCEMENT (K131658)W. L. Gore & Associates, Inc.2013-09-06
K-PACK II NEEDLE - 27G X 3/4 THIN WALL (K132233)Terumo Europe N.V.2013-09-06
COMPREHENSIVE REVERSE SHOULDER SCREWS (K132239)Biomet Manufacturing Corp2013-09-06
JUSHA-C31 MEDICAL DISPLAY (K131389)Nanjing Jusha Display Technology Co., Ltd.2013-09-06
ARIX FOOT SYSTEM (K131311)Jeil Medical Corporation2013-09-05
Z5MLB, Z5MLC (K131701)Z-Systems AG2013-09-05
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM (K123723)Synthes2013-09-05
STITCHKIT (K123811)Origami Surgical, LLC2013-09-05
PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 (K131452)St. Jude Medical Systems AB2013-09-05
ACUMED WRIST SPANNING PLATE (K131764)Acumed, LLC2013-09-05
TEPHAFLEX BRAIDED SUTURE (K132348)Tepha, Inc.2013-09-05
← Previous Next →

Track 2013 automatically

Every clearance here is in the API, with alerts when new ones post.